HealthcareEHR vendor, research group partner to expand clinical trial...

EHR vendor, research group partner to expand clinical trial access, diversity

Electronic health record vendor NextGen Healthcare and Circuit Clinical are teaming up to help providers connect diverse populations of patients to clinical trial access through federally qualified health centers, the companies said Wednesday.

NextGen has 14,000 provider and 300 health center clients, and the collaboration with Circuit Clinical, an integrated research organization, will improve clinical trial recruitment. The companies hope that will lead to enhanced treatment options and improved health outcomes for patients of color.

Patients participating in the trials will receive stipends and extra care visits without co-pays, allowing them to spend more time with their physicians, said Srinivas Velamoor, chief growth and strategy officer at NextGen Healthcare.

Research and clinical trials can benefit providers’ practice and care quality by giving clearer data on treatment efficacy across patient populations. During the pandemic, COVID-19 vaccine trials often underrepresented Black and Latino patients.

The lack of diversity in clinical trials has been a known problem in the healthcare industry, said Dr. Marcus Schabacker, president and CEO of ECRI.

Minority racial and ethnic groups comprise around 40% of the U.S. population, but 75% of the 32,000 individuals participating in 53 novel drug trials in 2020 were white, according to the U.S. Food and Drug Administration.

More than one-third of patients with kidney failure are Black, yet Black patients only account for 9% of kidney disease clinical trial participants, the American Kidney Fund found.

Clinical trials designed by pharmaceutical or medical device companies typically end up with a study population that is largely white and male due to research criteria and the frequent exclusion of women who are of child-bearing age and older people with comorbidities, Schabacker said.

Before participants are recruited by companies like NextGen, Schabacker suggested researchers should identify racial and ethnic subgroups to include as part of their study’s initial design as another measure to ensure the data is adequately representative of the overall population.

“It’s a really critical factor to make sure we develop pharmaceuticals and medical devices which are beneficial to all parts of the patient population,” he said. “In terms of health equity and access to healthcare, it’s a very important step.”

NextGen uses datasets from its health systems with information on patients’ socioeconomic status or demographics to identify participants to recruit with Circuit Clinical, Velamoor said.

“Most of these digital research networks today, they’re starting with de-identified data sets that look like they might be a good fit and trying to recruit them, versus starting with named patients and populations that are recommended by the actual doctors who take care of them,” Velamoor said.

Last month, the Food and Drug Administration released new guidance to assist organizations with creating a plan to diversify clinical trials by enrolling more participants from underrepresented populations.

The clinical trials partnership is also contributing to NextGen’s Community Health Collaborative, which offers providers data benchmarking, comparative analytics and reporting services, as well as a forum to discuss the best practices in advancing health equity among underserved populations, Velamoor said.

“The long term goal is to create a comprehensive solution that provides access to research-as-care to all the communities we serve,” he said.

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